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NCT05135559 · ClinicalTrials.gov registry record · Phase 3

A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors

A Phase 3 study of Haemophilia A and B With and Without Inhibitors, sponsored by Novo Nordisk A/S.

Active
Registry status
Phase 3
Development phase
153
Enrollment target
20
Study locations

NCT05135559: Active Phase 3 study of Haemophilia A and B With and Without Inhibitors, sponsored by Novo Nordisk A/S.

NCT05135559 is a Phase 3 study of Haemophilia A and B With and Without Inhibitors that is active but no longer recruiting, run by Novo Nordisk A/S. The registered enrollment target is 153 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05135559, a Phase 3 study of Haemophilia A and B With and Without Inhibitors, is active but no longer recruiting, sponsored by Novo Nordisk A/S.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
153 participants
Enrollment target
20
Study locations

Study Summary

This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use. Participants will have to inject the study medicine every day under the skin with a pen-injector. The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.

Primary Outcome

Count of episode(s)

Interventions

  • DRUG Concizumab

Study Locations (20)

Florida

  • Arnold Palmer Children's Hospital - Orlando
  • Nemours Child Orlando Hem/Onc. - Orlando

Georgia

  • Augusta Univ/Childrens Hosp-GA - Augusta
  • Memorial Health University Medical Center - Savannah

Louisiana

  • Children's Hosp-New Orleans - New Orleans
  • Ochsner Clinic Foundation - New Orleans

Texas

  • Cook Children's Hospital-Hematology-Oncology - Fort Worth
  • Texas Children's Hospital_Houston - Houston

California

  • Rady Childrens Hosp San Diego - San Diego

Colorado

  • University of Colorado Hospital - Aurora

Illinois

  • Childrens Hospital of Chicago - Chicago

Indiana

  • Indiana Hemophilia-Thromb Ctr - Indianapolis

Trial Details

FieldValue
Enrollment Target 153 participants
Start Date 2022-03-24
Est. Completion 2029-11-02
Phase Phase 3
Novo Nordisk A/S

431 total trials

What the registry record for NCT05135559 still lists

NCT05135559 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).

The record links to 1 condition, with Haemophilia A and B With and Without Inhibitors appearing as the primary indexed condition, and to 1 intervention - of which Concizumab is the first listed.

NCT05135559 names 20 study sites across 16 states, led by Florida, Georgia, Louisiana.

Frequently Asked Questions

What is clinical trial NCT05135559 about?

NCT05135559 is a clinical study titled "A Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors". This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use. Participants will have to inject the study medicine every day under the skin wi...

What is the current status of trial NCT05135559?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 153 participants. The study started on 2022-03-24. Estimated completion is 2029-11-02.

What conditions does trial NCT05135559 study?

This clinical trial studies the following conditions: Haemophilia A and B With and Without Inhibitors.

What interventions are being tested in trial NCT05135559?

The interventions under investigation include: Concizumab (DRUG).

Who is sponsoring clinical trial NCT05135559?

This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05135559 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT05135559's enrollment target sits among peer trials

153 1511th of 2000 higher than 488 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05135559, the US trial registry maintained by the National Library of Medicine. NCT05135559 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.